In Perfect Harmony: The NIH – FDA Clinical Trials Protocol Template

One of the most frequent exasperated questions I face when I talk to NIH stakeholders is, “Why can’t federal agencies harmonize more? Don’t you people ever talk to each other?!?” I am happy to share tangible proof that the clear answer is “Yes!”  Today, NIH and FDA released the final version of a template document I blogged about last March that will assist NIH-funded investigators in preparing Phase 2 and 3 IND/IDE trial protocols. In utilizing this template, investigators can prepare documents that will help enable efficient and speedy reviews by both the IRB and the FDA.

The final template was developed by a wide variety of stakeholders.  We received over 200 comments on the draft template, many of which have been incorporated into the final product.  Additionally, NIH and FDA collaborated with the non-profit organization, TransCelerate Biopharma in order to align our template with a template TransCelerate has been developing for industry-sponsored investigators. A shared template format with tailored instructions that fit each sectors’ needs will further facilitate the FDA review and help increase the efficiency of the clinical trial enterprise.

This being the digital age, NIH thought having a web-based platform where investigators could utilize the protocol template in an interactive fashion would be an essential tool.  With that in mind, NIH developed an Electronic Protocol Writing Tool.  We like to think of this as a sort of Turbo TaxTM for clinical trial protocols.  The tool allows for a collaborative approach to writing and reviewing protocols.  Investigators will be able to form a “protocol writing team” and assign different individuals with writing and reviewing roles.  The tool also makes it easy for the investigator to track the progress of the protocol, share comments between team members and keep accurate version control.  NIH is also considering future enhancements to the functionality of the tool as well as additional instructional and example text for other study types, such as behavioral clinical studies. I highly recommend that all investigators who plan on utilizing the NIH-FDA template take the e-Protocol Writer for a spin and provide us with their feedback.

With today’s release of the final protocol template and the e-Protocol Writer, NIH has taken another step towards enhancing our stewardship of NIH-funded clinical trials.  To read some additional perspectives on the importance of this initiative, please read a statement released today by NIH Director Dr. Francis Collins, as well as a blog published by the FDA.